Per the EU medical devices directives „European authorised representative“ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.Source: Medical Device Directive 93/42/EEC as amended by 2007/47/EC
In January 2012, an extensive guidance document was published by the EU Commission to further specify the role of an EU Auth. Rep. (refer to MEDDEV guidance document 2.5/10).
The Authorized Representative has certain obligations as defined by the relevant
Directives, such as:
- informing the competent authorities of his registered place of business
- keeping certain information at the disposal of the national authorities, such as declarations of conformity and technical documentation
The manufacturers may instruct his authorised representative to initiate certain procedures provided for in the conformity assessment annexes.
Source: MEDDEV 2.5/10
Often manufacturers decide against the appointment of an independent EU Auth. Rep. and simply use one of their distributors to take over the responsibilities mentioned above. We have thus compiled information as to „Why you should not appoint your Distributor as Authorized Representative?“. Learn more…
The above regulatory definition of an EU Auth. Rep. does not give indepth information of what the EAR really does for you. We have thus prepared a detailed text to give you an idea of what mdi Europa would do for you if appointed your EU Auth. Rep. Learn more…